NA

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. BIOMETRIK RISET INDONESIA
No Registry
Tanggal Input Registry : 29-03-2023

10-11-2022
90% Confidence Interval (CI) (%) AUC0-t (ng.h/mL) = 89.60-103.53 Cmax (ng/mL) = 83.18 - 102.66
90% Confidence Interval (CI) (%) AUC-Inf (ng.h/mL) = 89.67-103.55 T1/2 of T and R were respectively 2.80 ± 0.34 and 2.76 ± 0.37 h Tmax of T and R were respectively 0.75 (0.33 -2.50) h and 0.75 (0.50-3.00) h.
 
NA
BIOEQUIVALENCE STUDY OF SILDENAFIL 100 MG FILM-COATED TABLET MANUFACTURED BY PT MEGA LIFESCIENCES INDONESIA IN COMPARISON WITH SILDENAFIL 100 MG FILM-COATED TABLET, VIAGRA MANUFACTURED BY FAREVA AMBOISE, POCESUR-CISSE, FRANCE; IMPORTED BY PT PFIZER INDONESIA
Interventional
NA
36
 

Inclusion Criteria:

Participating subjects was fulfill the following inclusion criteria: a. Willing to participate and agree to sign informed consent, and be able to communicate well with the investigators. b. Healthy male subjects as determined by the medical screening assessments. c. Aged 18-55 years inclusive d. Married e. Body mass index within the range of 18.00 -25.00 kg/m2. f. Vital signs, after 10 minutes resting, within the following ranges: (i). Pulse rate: 60-90 bpm. (ii). Respiratory Rate: 12-20 x/minutes. (iii).Systolic blood pressure: 60 - 84 mmHg. (iv). Diastolic blood pressure: 60 - 84 mmHg. (v). Body temperature

Exclusion Criteria:

Any of the following criteria was exclude the subject from the study: a. Participate in another study within 3 (three) months prior to the first day of study drug administration. b. Smoker or smoking more than 10 (ten) cigarettes per day. c. Intake of any prescription drug or non-prescription drug within 7 days prior the first day of drug administration of this study. d. Blood donation or blood loss of 300 mL (or more) within 3 (three) months prior to the frist day of study drug administration. e. History of drug and/or alcohol abuse or dependency within 12 months prior to the first day of study drug administration. f. Known hypersensitivity or contraindication to the study drug. g. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study, e.g. gastrointestinal disease including gastric or duodenal ulcer or history of gastric surgery. h. History of any bleeding or coagulative disorders. i. Clinically significant hematology abnormalities j. Clinically significant urinalysis abnormalities k. Renal insufficiency (plasma's creatinine concentration ≥ 1.50 mg/dL). l. History or presence of any liver dysfunction (SGPT, alkaline phosphate, total bilirubin ≥ 1.5 ULN). m. Positive result of HBsAg, HCV and/or HIV test.
 
KET-1005/UN2.F1/ETIK/PPM.00.02/2022
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Tri Septiani